MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for PYXIS 4000 manufactured by Pyxis Technologies, Inc..
[94399976]
A user attempting to place the pyxis machines in "critical override" mode inadvertently disabled all machines across the hospital. This was apparently very easy to do - with only a single prompt before the machines were completely disabled. All of the pyxis machines were inaccessible for about 24 mins. The pt who is the subject of this report required midazolam for compliance with the ventilator, but this was delayed by about 10 mins while i was physically and run up to the nurse. While the pt waited they experienced reduced ventilator volumes, tachycardia, obvious discomfort, and there oxygen saturation began to fall from 100% to 95% before the midazolam arrived. This writer has learned this is the second such event this year where pyxis machines were completely disabled due to a product use error by someone who inadvertently disabled all machines. A simple "are you sure you want to do this" pop-up is not sufficient for such a permanent action that has the consequence of removing access to medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073834 |
| MDR Report Key | 7100747 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-26 |
| Date Added to Maude | 2017-12-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PYXIS |
| Generic Name | MEDICAL COMPUTER AND SOFTWARE |
| Product Code | LNX |
| Date Received | 2017-12-08 |
| Model Number | 4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYXIS TECHNOLOGIES, INC. |
| Manufacturer Address | 45911 PORT ST MI 48170 US 48170 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-08 |